Ofatumumab combined with chlorambucil for previously untreated chronic lymphocytic leukemia: a phase I/II, open-label study in Japan
Ofatumumab combined with chlorambucil for previously untreated chronic lymphocytic leukemia: a phase I/II, open-label study in Japan
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奥法木单抗联合苯丁酸氮芥治疗既往未经治疗的慢性淋巴细胞白血病：日本的一项 I/II 期开放标签研究
DOI：
10.1007/s12185-017-2233-1
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发表时间：
2017
期刊：
影响因子：
2.1
通讯作者：
Ando Kiyoshi
中科院分区：
文献类型：
--
作者：
Hatake Kiyohiko;Ogura Michinori;Takada Kohichi;Taniwaki Masafumi;Zhang Fanghong;Fujita Taizo;Ando Kiyoshi
患有慢性淋巴细胞白血病（CLL）的老年/共病患者需要低毒性治疗。在国际上，这类患者的标准治疗是苯丁酸氮芥和抗CD 20治疗;然而，苯丁酸氮芥在日本尚未获得批准。本研究的目的是评价奥法木单抗联合苯丁酸氮芥治疗不适合氟达拉滨治疗的既往未经治疗的CLL日本患者的安全性、疗效和药代动力学。本研究入组并治疗了10例患者，所有患者均接受了至少一剂研究药物。最初在3名患者中证实了治疗的耐受性。由独立审查委员会（IRC）通过计算机断层扫描确定的总体缓解率为50%。所有患者在随访时均存活，仅1例患者出现疾病进展。最常见的治疗相关不良事件（AE）为血小板减少症（n= 10）、中性粒细胞减少症（n= 9）和皮疹（n= 6）。发生了1起与研究药物相关的3级严重AE（缺氧）。结果表明，奥法木单抗联合苯丁酸氮芥是日本CLL患者的有效治疗方法，且安全性可控。
Elderly/comorbid patients with chronic lymphocytic leukemia (CLL) require low-toxicity treatments. Internationally, the standard treatment for such patients is chlorambucil and an anti-CD20 therapy; however, chlorambucil is not approved in Japan. The aim of the present study was to evaluate the safety, efficacy and pharmacokinetics of ofatumumab in combination with chlorambucil in Japanese patients with previously untreated CLL who were inappropriate for fludarabine-based therapy. Ten patients were enrolled and treated in this study, all of whom received at least one dose of the study drugs. The tolerability of the treatment was confirmed initially with three patients. The overall response rate was 50%, as determined by the Independent Review Committee (IRC) with computerized tomography. All patients were alive at follow-up, and only one patient had progressive disease. The most common treatment-related adverse events (AEs) were thrombocytopenia (n= 10), neutropenia (n= 9) and rash (n= 6). One grade 3 serious AE related to the study drug occurred (hypoxia). The results indicate that ofatumumab combined with chlorambucil is an effective treatment for Japanese CLL patients, with a manageable safety profile.